Pitasor 2

Dyslipidemias or mixed dyslipidemia. Familial hypercholesterolemia.

Adult Initially 2 mg once daily. Usual maintenance dose: 1-4 mg once daily. Max: 4 mg once daily. Severe renal impairment (GFR 15-29 mL/min/1.73 m²), not receiving dialysis, moderate renal impairment (GFR 30-59 mL/min/1.73 m²), ESRD receiving hemodialysis Initially 1 mg daily. Max: 2 mg daily.

May be taken with or without food.

Hypersensitivity. Active liver disease including unexplained, persistent elevations in serum aminotransferase (transaminase) conc. Concomitant use w/ ciclosporin. Pregnancy & lactation.

Discontinue therapy if myopathy & rhabdomyolysis w/ acute renal failure secondary to myoglobinuria is diagnosed or suspected; there is myalgia at calf, back or whole body; markedly elevated creatinine kinase levels occur; transaminase level is >3x ULN. Consider temporary discontinuation in conditions predisposing to renal failure secondary to rhabdomyolysis/myoglobinuria (eg, sepsis, hypotension, dehydration, major surgery, trauma, severe metabotic, endocrine & electrolyte disorder or uncontrolled seizures). Interrupt treatment if serious liver injury w/ clinical symptoms &/or hyperbilirubinemia or jaundice occur. Immune-mediated necrotizing myopathy; increased HbA1c, serum glucose, & serum transaminase levels. Increased risk of severe myopathy/rhabdomyolysis w/ higher doses. Patients w/ pre-existing amyotrophic lateral sclerosis (ALS); inadequately treated hypothyroidism. Perform LFTs before & 6 & 12 wk after treatment; every 6 mth in patients who routinely use the drug. Monitor increases in serum transaminase level. Assess lipid levels 4 wk after dose initiation or titration. Heavy alcohol use. Concomitant use w/ digoxin & warfarin. Increased risk of myopathy or rhabdomyolysis w/ azole antifungals eg, ketoconazole, itraconazole; macrolides eg, erythromycin, clarithromycin; HIV PIs eg, indinavir, ritonavir, nelfinavir, saquinavir; verapamil; diltiazem; gemfibrozil; nicotinic acid; cyclosporine; amiodarone; colchicine. Avoid concomitant use w/ gemfibrozil. Moderate to severe renal impairment (GFR 15-59 mL/min/1.73 m²) or ESRD in patients receiving hemodialysis. Avoid use in ped patients. Elderly >65 yr.

Constipation, diarrhea; backache, myalgia, limb pain, muscle disorder, rhabdomyolysis.

Increased bioavailability w/ OATP1B1 inhibitors eg, cyclosporine, erythromycin, rifampin. Increased exposure w/ cyclosporine; erythromycin; rifampin. Decreased peak plasma conc & increased AUC w/ digoxin; grapefruit juice. Decreased peak plasma conc & AUC of digoxin; diltiazem HCl ER. Decreased peak plasma conc & AUC w/ itraconazole. Increased peak plasma conc & AUC w/ diltiazem HCl ER. Increased risk of myopathy or rhabdomyolysis w/ gemfibrozil. May disturb peak plasma conc & AUC w/ HIV PIs. Increased risk of myopathy w/ antilipemic dosages of niacin (≥1 g daily). Concomitant use w/ other fibric acid derivatives eg, fenofibrate; warfarin.

Dyslipidaemic Agents

C10AA08 - pitavastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.

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